Who else makes this device?

Name: Pointe AST Reagent
Brand: Pointe AST Reagent

Clinical Chemistry › Test SystemsNadh Oxidation/Nad Reduction, Ast/Sgot

Pointe AST Reagent

Pointe AST Reagent packaged for use on the Mindray BA800. 5 x 67ml R1, 5 x 17ml R2. For the quantitative determination of Aspartate Aminotransferase (AST) in human serum.

Registry build 21.09.26

2manufacturers in China registered for this device type

1catalogue number

4recalls on this code

Who Else Makes It

Concentrated in Jilin (1), Shandong (1).

Chinese manufacturers registered for FDA product code CIT
Manufacturer	City	Province	Registered as	Device types
Dirui Industrial Co., Ltd.	Changchun	Jilin	Contract manufacturer	84
Biobase Biodustry(Shandong)Co., Ltd.	Jinan	Shandong	Manufacturer	70

Record

Regulatory record for Pointe AST Reagent
Listed by	Horiba Instruments Incorporated, United States
FDA product code	CIT
Device type	Nadh Oxidation/Nad Reduction, Ast/Sgot
Device class	Class 2
Regulation	21 CFR 862.1100
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K941132
Record published	2021-01-30
Record revised	2025-10-02 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Pointe AST Reagent
Catalogue number	Size	Status
16-A7561-420		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Biobase	Biobase Biodustry(Shandong)Co., Ltd.	19
AST	Randox Laboratories Limited	10
JAS Diagnostics	Drew Scientific, Ltd.	7
Synermed®	Infrared Laboratory Systems LLC	7
Pointe Scientific, Inc.	Horiba Instruments Incorporated	5
AU	Beckman Coulter, Inc.	4
Architect	Abbott Ireland	4
Synchron	Beckman Coulter, Inc.	4
ACE	Alfa Wassermann	4
Architect	Abbott Medical	3
Alinity	Abbott Ireland	3
Architect	Abbott Laboratories	3

Showing 12 of 62. All products under Nadh Oxidation/Nad Reduction, Ast/Sgot

Recalls Naming This Product

3 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Pointe AST Reagent
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Horiba Instruments Incorporated	510(k) number	2012-02-15	Class III	Error in labeling	A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert	119.168L across All lots	2017-06-02
Horiba Instruments Incorporated	510(k) number	2008-08-25	Not classified	Material/Component Contamination	The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.	109 kits	2009-11-27
Horiba Instruments Incorporated	510(k) number	2008-08-25	Not classified	Material/Component Contamination	The R1 component may be contaminated with Serratia liquefaciens, resulting decreased absorbances and failure of the reagent to produce test results.	25 vials	2009-11-27

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2012-10-10	Class II	Software design	Horiba Medical is recalling the ABX PENTRA AST CP because during the AST application validation on the Pentra C200 using an Audit Systems linearity kit, it was determined that two higher values for AST (expected at 800 U/L and 1000 U/L) we	66886 units	2013-09-12

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.